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NCT Number: NCT06645184

Adding Appetite Stimulants to an ONS in Older Adults

Study to determine whether adding specific nutrients to a high-protein oral nutritional support (ONS), with and without fibre can reduce the feeling of satiety and may increase appetite in adults older than 65 years. This contributes to research into a new type of nutritional nutrition for people with disease related malnutrition (DRM)

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 65 years of age or older
  • Able to consume high energy and/or high protein ONS at discretion of the Investigator
  • Written informed consent
  • Willing and able to refrain from smoking during the visits
  • Able to speak and read in Dutch to communicate with the site staff and comply with the instructions and requirements of the study.

Exclusion criteria

  • Any known condition that interferes with the gastric emptying (e.g., gastroparesis, gastric stoma, hypothyroidism, hyperthyroidism, multiple sclerosis, Parkinson disease).
  • Any known metabolic condition that interferes with the breakdown of amino acids (e.g. arginase deficiency, urea cycle disorder)
  • Known history of gastric surgery e.g. (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding, gastric balloon.
  • Any known chronic/continuous use, and/or within 24-48h before the visit, of medication that strongly affects with gastric emptying or gastric acid secretion (e.g., metoclopramide, opioid analgesics, calcium channel blockers, Beta-Adrenergic Receptor Agonists, H2 receptor antagonists, proton pump inhibitors; tricyclic antidepressants such as amitriptyline, imipramine, systemic steroids)
  • Known active cancer treatment 4 weeks prior the study start
  • Body Mass Index >= 30.0 kg/m²
  • Presence of Diabetes Mellitus (self-reported or the use of Diabetes medication: i.e., insulin, biguanides, DPP-4 inhibitors, GLP-1 receptor agonists)
  • Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or Alzheimer's disease
  • Known renal dysfunction with protein restriction diet
  • Known allergy to cow's milk protein
  • Known allergy to soy
  • Known galactosaemia
  • Known lactose intolerance
  • Excessive alcohol consumption (use of > 14 units per week for women or > 21 units per week for men, on average during the past 6 months).
  • Drug abuse based on investigator's judgement.
  • Any contraindication to oral feeding per se being: any degree of dysphagia, gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis.
  • Enrolment in any other studies involving investigational or marketed products concomitantly or within two weeks prior to baseline
  • Employees, family members or other relatives of employees of the participating centre or of Danone Global Research & Innovation Center.

Treatment and study plan

Oral Nutritional Supplement

Dietary Supplement

During 4 test days, 1 bottle (125ML) of High protein ONS with or without fibre and with or without the added nutrients will be consumed by the subjects. During each test day, the subjects will complete questionnaires related to appetite and liking of the product from baseline (-5 minutes of start consumption of study product) until 120 minutes after start consumption of study product.

Primary outcomes

  1. composite satiety score (CSS)

    Time frame: 120 minutes

    The main outcome parameter in this study is the composite satiety score (CSS), measured from baseline (-5 minutes) until 120 minutes after starting the consumption of the study product.

Secondary outcomes

  1. Satiety after 120 min

    Time frame: more than 120 minutes

    Satiety, fullness, hunger, prospective food consumption measured from baseline until 120 minutes after starting the consumption of the study product measured with composite satiety score questionnaire

  2. Volume consumed

    Time frame: 120 minutes

    Adherence to use of the study product, defined as volume consumed within 10 minutes relative to 1 serving [%]

Study contacts

Contact information is provided by the study sponsor or research team.

Danone Nutricia research

CONTACT

[email protected]

+31 30 2095 000

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Official study title

Effects of Adding Appetite Stimulants to a Fibre Containing High-Protein ONS on Appetite-Related Outcomes in Older Adults

Acronym: APPOLO II

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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